| Primary Device ID | 27290015409012 |
| NIH Device Record Key | de39ae61-0732-4090-b532-005f0a32dcba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AG Cuffill Kruuse - VET |
| Version Model Number | AG Cuffill Kruuse - VET |
| Catalog Number | HSCUFF0052 |
| Company DUNS | 514824387 |
| Company Name | HOSPITECH RESPIRATION LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +97239191648 |
| yoel@hospitech.co.il | |
| Phone | +97239191648 |
| yoel@hospitech.co.il |
| Handling Environment Temperature | Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between -32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015409018 [Primary] |
| GS1 | 17290015409015 [Package] Contains: 07290015409018 Package: carton [10 Units] In Commercial Distribution |
| GS1 | 27290015409012 [Package] Contains: 17290015409015 Package: carton [200 Units] In Commercial Distribution |
| BSK | Cuff, Tracheal Tube, Inflatable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-03 |
| Device Publish Date | 2019-03-05 |
| 27290015409012 - AG Cuffill Kruuse - VET | 2019-04-03The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways. |
| 27290015409012 - AG Cuffill Kruuse - VET | 2019-04-03 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi |
| 17290015409107 - AG100s control unit | 2019-04-03 AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuf |
| 17290015409114 - AG Connection KIT | 2019-04-03 AG Connection KIT is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff press |
| 27290015409128 - AnapnoGuard™ Endotracheal Tube 7.0mm | 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu |
| 27290015409159 - AnapnoGuard™ Endotracheal Tube 7.5mm | 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu |
| 27290015409166 - AnapnoGuard™ Endotracheal Tube 8.0mm | 2019-04-03 The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacu |
| 27290015409005 - AG Cuffill (cmH2O) | 2019-03-21 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi |
| 17290015409039 - AG Cuffill (mmHg) | 2019-03-21 The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringi |